Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 11:35 PM
Study NCT ID:
NCT01512160
Status:
TERMINATED
Last Update Posted:
2013-06-28
First Post:
2011-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy Of Pf-04531083 In Treating Post-Surgical Dental Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007052', 'term': 'Ibuprofen'}], 'ancestors': [{'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Study was terminated for futility based on results of interim analysis.'}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'PF-04531083 1000 mg', 'description': 'Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.', 'otherNumAtRisk': 22, 'otherNumAffected': 13, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'PF-04531083 2000 mg', 'description': 'Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.', 'otherNumAtRisk': 23, 'otherNumAffected': 10, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Ibuprofen 400 mg', 'description': 'Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.', 'otherNumAtRisk': 22, 'otherNumAffected': 8, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.', 'otherNumAtRisk': 23, 'otherNumAffected': 5, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Blood bilirubin unconjugated increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Pain Relief (TOTPAR) Score From 0 to 6 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04531083 1000 mg', 'description': 'Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG001', 'title': 'PF-04531083 2000 mg', 'description': 'Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG002', 'title': 'Ibuprofen 400 mg', 'description': 'Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '1.5', 'groupId': 'OG001'}, {'value': '8.8', 'spread': '1.5', 'groupId': 'OG002'}, {'value': '5.3', 'spread': '1.5', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG003'], 'paramType': 'Least squares (LS) mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.1', 'ciLowerLimit': '-4.3', 'ciUpperLimit': '2.2', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.9', 'groupDescription': 'Analysis of co-variance (ANCOVA) model was used with treatment as a fixed effect and baseline pain intensity as a covariate. LS mean estimates of the treatment difference along with 90 percent (%) confidence interval (CI) was presented.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.9', 'ciLowerLimit': '-4.1', 'ciUpperLimit': '2.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.9', 'groupDescription': 'ANCOVA model was used with treatment as a fixed effect and baseline pain intensity as a covariate. LS mean estimates of the treatment difference along with 90% CI was presented.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '3.5', 'ciLowerLimit': '0.3', 'ciUpperLimit': '6.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.9', 'groupDescription': 'ANCOVA model was used with treatment as a fixed effect and baseline pain intensity as a covariate. LS mean estimates of the treatment difference along with 90% CI was presented.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '0 to 6 hours', 'description': 'TOTPAR \\[6\\] was defined as the area under the pain relief (PR) curve through the first 6 hours after dosing. Area under the curve (AUC) was calculated using the trapezoid rule with PR was assumed to be 0 at time=0. PR assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at 15, 30, 45, minutes and at different time points during the study up to 6 hours post-dose. Total score range for TOTPAR \\[6\\]: 0 (worst) - 24 (best), higher value of TOTPAR indicated greater degree of PR.', 'unitOfMeasure': 'units on a scale*hour', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. Missing PR values were imputed using last observation carried forward (LOCF).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Peak Pain Relief (PPR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04531083 1000 mg', 'description': 'Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG001', 'title': 'PF-04531083 2000 mg', 'description': 'Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG002', 'title': 'Ibuprofen 400 mg', 'description': 'Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'A Little', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Some', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'A Lot', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Complete', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0 to 24 hours', 'description': 'PPR was defined as the highest PR score achieved at any time point during the evaluation period, prior to rescue medication. PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration.'}, {'type': 'SECONDARY', 'title': 'Time-specific Pain Relief (PR) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04531083 1000 mg', 'description': 'Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG001', 'title': 'PF-04531083 2000 mg', 'description': 'Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG002', 'title': 'Ibuprofen 400 mg', 'description': 'Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}], 'classes': [{'title': '0 hours (n=22, 23, 22, 23)', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG002'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG003'}]}]}, {'title': '15 minutes (n=22, 23, 22, 23)', 'categories': [{'measurements': [{'value': '0.59', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '0.78', 'spread': '0.95', 'groupId': 'OG001'}, {'value': '0.59', 'spread': '0.91', 'groupId': 'OG002'}, {'value': '0.57', 'spread': '0.73', 'groupId': 'OG003'}]}]}, {'title': '30 minutes (n=22, 23, 22, 23)', 'categories': [{'measurements': [{'value': '0.82', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '1.04', 'spread': '1.07', 'groupId': 'OG001'}, {'value': '1.23', 'spread': '1.23', 'groupId': 'OG002'}, {'value': '1.04', 'spread': '1.02', 'groupId': 'OG003'}]}]}, {'title': '45 minutes (n=22, 23, 22, 23)', 'categories': [{'measurements': [{'value': '0.91', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '1.26', 'spread': '1.18', 'groupId': 'OG001'}, {'value': '1.55', 'spread': '1.22', 'groupId': 'OG002'}, {'value': '1.35', 'spread': '1.07', 'groupId': 'OG003'}]}]}, {'title': '1 hour (n=22, 23, 22, 23)', 'categories': [{'measurements': [{'value': '0.86', 'spread': '0.99', 'groupId': 'OG000'}, {'value': '1.13', 'spread': '1.06', 'groupId': 'OG001'}, {'value': '1.73', 'spread': '1.28', 'groupId': 'OG002'}, {'value': '1.39', 'spread': '1.34', 'groupId': 'OG003'}]}]}, {'title': '1.5 hours (n=22, 23, 22, 23)', 'categories': [{'measurements': [{'value': '0.82', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '0.91', 'spread': '1.12', 'groupId': 'OG001'}, {'value': '1.77', 'spread': '1.38', 'groupId': 'OG002'}, {'value': '1.30', 'spread': '1.22', 'groupId': 'OG003'}]}]}, {'title': '2 hours (n=15, 13, 20, 16)', 'categories': [{'measurements': [{'value': '1.07', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '1.77', 'spread': '0.93', 'groupId': 'OG001'}, {'value': '1.90', 'spread': '1.37', 'groupId': 'OG002'}, {'value': '1.63', 'spread': '1.26', 'groupId': 'OG003'}]}]}, {'title': '3 hours (n=11, 10, 15, 12)', 'categories': [{'measurements': [{'value': '2.27', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '2.30', 'spread': '1.06', 'groupId': 'OG001'}, {'value': '2.73', 'spread': '0.96', 'groupId': 'OG002'}, {'value': '2.25', 'spread': '1.06', 'groupId': 'OG003'}]}]}, {'title': '4 hours (n=11, 10, 15, 10)', 'categories': [{'measurements': [{'value': '2.27', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '2.20', 'spread': '0.92', 'groupId': 'OG001'}, {'value': '2.87', 'spread': '0.92', 'groupId': 'OG002'}, {'value': '2.60', 'spread': '1.17', 'groupId': 'OG003'}]}]}, {'title': '6 hours (n=11, 9, 15, 9)', 'categories': [{'measurements': [{'value': '2.64', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '2.67', 'spread': '0.87', 'groupId': 'OG001'}, {'value': '2.87', 'spread': '0.92', 'groupId': 'OG002'}, {'value': '3.11', 'spread': '0.78', 'groupId': 'OG003'}]}]}, {'title': '8 hours (n=10, 9, 15, 8)', 'categories': [{'measurements': [{'value': '2.70', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '2.67', 'spread': '1.32', 'groupId': 'OG001'}, {'value': '2.60', 'spread': '0.91', 'groupId': 'OG002'}, {'value': '3.13', 'spread': '0.83', 'groupId': 'OG003'}]}]}, {'title': '24 hours (n=8, 7, 8, 7)', 'categories': [{'measurements': [{'value': '3.63', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '3.86', 'spread': '0.38', 'groupId': 'OG001'}, {'value': '3.38', 'spread': '0.74', 'groupId': 'OG002'}, {'value': '3.71', 'spread': '0.49', 'groupId': 'OG003'}]}]}, {'title': 'Prior to RM (n=14, 16, 14, 16)', 'categories': [{'measurements': [{'value': '0.14', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '0.25', 'spread': '0.58', 'groupId': 'OG001'}, {'value': '0.50', 'spread': '0.65', 'groupId': 'OG002'}, {'value': '0.25', 'spread': '0.45', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 24 hours, prior to rescue medication (RM)', 'description': 'PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete) at each relevant time points.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. n=number of participants evaluable for this measure at specified time point.'}, {'type': 'SECONDARY', 'title': 'Time-specific Pain Intensity Difference (PID) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04531083 1000 mg', 'description': 'Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG001', 'title': 'PF-04531083 2000 mg', 'description': 'Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG002', 'title': 'Ibuprofen 400 mg', 'description': 'Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}], 'classes': [{'title': '15 minutes (n=22, 23, 22, 23)', 'categories': [{'measurements': [{'value': '0.14', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '0.65', 'groupId': 'OG001'}, {'value': '0.18', 'spread': '0.39', 'groupId': 'OG002'}, {'value': '0.17', 'spread': '0.39', 'groupId': 'OG003'}]}]}, {'title': '30 minutes (n=22, 23, 22, 23)', 'categories': [{'measurements': [{'value': '0.18', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '0.35', 'spread': '0.78', 'groupId': 'OG001'}, {'value': '0.41', 'spread': '0.67', 'groupId': 'OG002'}, {'value': '0.35', 'spread': '0.71', 'groupId': 'OG003'}]}]}, {'title': '45 minutes (n=22, 23, 22, 23)', 'categories': [{'measurements': [{'value': '0.23', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '0.30', 'spread': '0.88', 'groupId': 'OG001'}, {'value': '0.59', 'spread': '0.67', 'groupId': 'OG002'}, {'value': '0.35', 'spread': '0.83', 'groupId': 'OG003'}]}]}, {'title': '1 hour (n=22, 23, 22, 23)', 'categories': [{'measurements': [{'value': '0.14', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '0.83', 'groupId': 'OG001'}, {'value': '0.68', 'spread': '0.72', 'groupId': 'OG002'}, {'value': '0.39', 'spread': '1.03', 'groupId': 'OG003'}]}]}, {'title': '1.5 hours (n=22, 23, 22, 23)', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.88', 'groupId': 'OG001'}, {'value': '0.68', 'spread': '0.78', 'groupId': 'OG002'}, {'value': '0.26', 'spread': '1.01', 'groupId': 'OG003'}]}]}, {'title': '2 hours (n=15, 13, 20, 16)', 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '0.69', 'spread': '0.48', 'groupId': 'OG001'}, {'value': '0.75', 'spread': '0.97', 'groupId': 'OG002'}, {'value': '0.44', 'spread': '0.96', 'groupId': 'OG003'}]}]}, {'title': '3 hours (n=11, 10, 15, 12)', 'categories': [{'measurements': [{'value': '0.82', 'spread': '0.40', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '0.67', 'groupId': 'OG001'}, {'value': '1.20', 'spread': '0.68', 'groupId': 'OG002'}, {'value': '0.83', 'spread': '0.94', 'groupId': 'OG003'}]}]}, {'title': '4 hours (n=11, 10, 15, 10)', 'categories': [{'measurements': [{'value': '0.91', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '0.90', 'spread': '0.57', 'groupId': 'OG001'}, {'value': '1.20', 'spread': '0.56', 'groupId': 'OG002'}, {'value': '1.20', 'spread': '0.63', 'groupId': 'OG003'}]}]}, {'title': '6 hours (n=11, 9, 15, 9)', 'categories': [{'measurements': [{'value': '0.91', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '1.22', 'spread': '0.44', 'groupId': 'OG001'}, {'value': '1.20', 'spread': '0.68', 'groupId': 'OG002'}, {'value': '1.44', 'spread': '0.53', 'groupId': 'OG003'}]}]}, {'title': '8 hours (n=10, 9, 15, 8)', 'categories': [{'measurements': [{'value': '1.00', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '1.22', 'spread': '0.67', 'groupId': 'OG001'}, {'value': '1.20', 'spread': '0.56', 'groupId': 'OG002'}, {'value': '1.50', 'spread': '0.76', 'groupId': 'OG003'}]}]}, {'title': '24 hours (n=8, 7, 8, 7)', 'categories': [{'measurements': [{'value': '1.63', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '1.86', 'spread': '0.38', 'groupId': 'OG001'}, {'value': '1.63', 'spread': '0.74', 'groupId': 'OG002'}, {'value': '1.86', 'spread': '0.69', 'groupId': 'OG003'}]}]}, {'title': 'Prior to RM (n=14, 16, 14, 16)', 'categories': [{'measurements': [{'value': '-0.57', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '-0.44', 'spread': '0.51', 'groupId': 'OG001'}, {'value': '-0.29', 'spread': '0.61', 'groupId': 'OG002'}, {'value': '-0.50', 'spread': '0.52', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 24 hours, prior to RM', 'description': 'Pain intensity was assessed on a categorical scale ranging from 0 (none), 1 (mild), 2 (moderate) and 3 (severe). PID was calculated as pain intensity at baseline minus pain intensity at the respective post-baseline visit.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. n=number of participants evaluable for this measure at specified time point.'}, {'type': 'SECONDARY', 'title': 'Summed Pain Intensity Difference (SPID) Score at 6 Hours and 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04531083 1000 mg', 'description': 'Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG001', 'title': 'PF-04531083 2000 mg', 'description': 'Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG002', 'title': 'Ibuprofen 400 mg', 'description': 'Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}], 'classes': [{'title': 'SPID 0-6', 'categories': [{'measurements': [{'value': '0.9', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '4.1', 'spread': '1.1', 'groupId': 'OG002'}, {'value': '1.4', 'spread': '1.1', 'groupId': 'OG003'}]}]}, {'title': 'SPID 0-24', 'categories': [{'measurements': [{'value': '4.7', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '5.3', 'groupId': 'OG001'}, {'value': '13.3', 'spread': '5.4', 'groupId': 'OG002'}, {'value': '5.7', 'spread': '5.3', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.4', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '1.9', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.4', 'groupDescription': 'SPID 0-6: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.3', 'ciLowerLimit': '-2.7', 'ciUpperLimit': '2.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.4', 'groupDescription': 'SPID 0-6: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.8', 'ciLowerLimit': '0.4', 'ciUpperLimit': '5.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.4', 'groupDescription': 'SPID 0-6: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-1.0', 'ciLowerLimit': '-12.6', 'ciUpperLimit': '10.5', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.0', 'groupDescription': 'SPID 0-24: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.1', 'ciLowerLimit': '-11.5', 'ciUpperLimit': '11.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '6.9', 'groupDescription': 'SPID 0-24: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '7.6', 'ciLowerLimit': '-4.0', 'ciUpperLimit': '19.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '7.0', 'groupDescription': 'SPID 0-24: LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '0 to 6, 0 to 24 hours', 'description': 'Pain intensity was assessed on a categorical scale ranging from 0 (none), 1 (mild), 2 (moderate) and 3 (severe). PID was calculated as pain intensity at baseline minus pain intensity at the respective post-baseline visit. The SPID at 6 and 24 hours was derived by calculating the area under the PID effect curve through the first 6 or 24 hours post-dose respectively. The AUC was calculated using the trapezoid rule. Total score range: -6 (worst) to 18 (best) for SPID 0-6, and -24 (worst) to 72 (best) for SPID 0-24. Higher value of SPID indicated greater degree of pain relief.', 'unitOfMeasure': 'units on a scale*hour', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. Missing SPID values were imputed using LOCF.'}, {'type': 'SECONDARY', 'title': 'Total Pain Relief (TOTPAR) Score From 0 to 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04531083 1000 mg', 'description': 'Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG001', 'title': 'PF-04531083 2000 mg', 'description': 'Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG002', 'title': 'Ibuprofen 400 mg', 'description': 'Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.8', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '20.7', 'spread': '7.3', 'groupId': 'OG001'}, {'value': '30.8', 'spread': '7.4', 'groupId': 'OG002'}, {'value': '21.5', 'spread': '7.3', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.2', 'ciLowerLimit': '-15.6', 'ciUpperLimit': '16.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.5', 'groupDescription': 'LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.8', 'ciLowerLimit': '-16.5', 'ciUpperLimit': '14.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.4', 'groupDescription': 'LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '9.3', 'ciLowerLimit': '-6.6', 'ciUpperLimit': '25.1', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.5', 'groupDescription': 'LS mean estimates of the treatment difference along with 90% CI were based on ANCOVA model including treatment as a fixed effect and baseline pain intensity as a covariate.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '0 to 24 hours', 'description': 'TOTPAR \\[24\\] was defined as the area under the pain relief (PR) curve through the 24 hours after dosing. Area under the curve (AUC) was calculated using the trapezoid rule with PR assumed to be 0 at time=0. PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at 15, 30, 45, minutes and at different time points during the study up to 24 hours post-dose. Total score range for TOTPAR \\[24\\]: 0 (worst) - 96 (best), higher value of TOTPAR indicated greater degree of PR.', 'unitOfMeasure': 'units on a scale*hour', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. Missing TOTPAR values were imputed using LOCF.'}, {'type': 'SECONDARY', 'title': 'Time to Onset of First Perceptible Pain Relief (PR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04531083 1000 mg', 'description': 'Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG001', 'title': 'PF-04531083 2000 mg', 'description': 'Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG002', 'title': 'Ibuprofen 400 mg', 'description': 'Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '0.8'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '0.4'}, {'value': '0.4', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '0.5'}, {'value': '0.4', 'groupId': 'OG003', 'lowerLimit': '0.3', 'upperLimit': '0.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.8', 'ciLowerLimit': '0.5', 'ciUpperLimit': '1.5', 'groupDescription': 'Hazard Ratio (HR) estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.2', 'ciLowerLimit': '0.7', 'ciUpperLimit': '2.1', 'groupDescription': 'HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.1', 'ciLowerLimit': '0.6', 'ciUpperLimit': '2.0', 'groupDescription': 'HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '0 to 24 hours', 'description': "Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment they first began to experience any relief.", 'unitOfMeasure': 'hours', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration.'}, {'type': 'SECONDARY', 'title': 'Time to Onset of First Meaningful Pain Relief (PR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04531083 1000 mg', 'description': 'Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG001', 'title': 'PF-04531083 2000 mg', 'description': 'Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG002', 'title': 'Ibuprofen 400 mg', 'description': 'Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '5.6'}, {'value': '4.9', 'comment': 'Upper limit of 90% confidence interval was not estimable due to empirical distribution of the data.', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': 'NA'}, {'value': '3.3', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '4.2'}, {'value': '3.5', 'groupId': 'OG003', 'lowerLimit': '2.8', 'upperLimit': '4.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.0', 'ciLowerLimit': '0.5', 'ciUpperLimit': '2.1', 'groupDescription': 'HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.9', 'ciLowerLimit': '0.4', 'ciUpperLimit': '1.8', 'groupDescription': 'HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.5', 'ciLowerLimit': '0.7', 'ciUpperLimit': '2.9', 'groupDescription': 'HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '0 to 24 hours', 'description': "Participants evaluated the time to first meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment they first began to experience meaningful relief.", 'unitOfMeasure': 'hours', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration.'}, {'type': 'SECONDARY', 'title': 'Time to First Use of Rescue Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04531083 1000 mg', 'description': 'Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG001', 'title': 'PF-04531083 2000 mg', 'description': 'Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG002', 'title': 'Ibuprofen 400 mg', 'description': 'Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'comment': 'Upper limit of 90% confidence interval was not estimable due to empirical distribution of the data.', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': 'NA'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': '10.4'}, {'value': '11.1', 'comment': 'Upper limit of 90% confidence interval was not estimable due to empirical distribution of the data.', 'groupId': 'OG002', 'lowerLimit': '2.4', 'upperLimit': 'NA'}, {'value': '3.2', 'groupId': 'OG003', 'lowerLimit': '2.0', 'upperLimit': '12.9'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.0', 'ciLowerLimit': '0.6', 'ciUpperLimit': '1.9', 'groupDescription': 'HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.3', 'ciLowerLimit': '0.7', 'ciUpperLimit': '2.4', 'groupDescription': 'HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.7', 'ciLowerLimit': '0.4', 'ciUpperLimit': '1.3', 'groupDescription': 'HR estimates of the treatment difference along with 90% CI were based Cox proportional hazards model including treatment and baseline pain intensity as fixed effects.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '1.5 to 24 hours', 'description': 'Time to first use of rescue medication (2 tablets of acetaminophen 500 mg as starting dose) was calculated by subtracting time of first administration of study medication from the rescue medication administration time.', 'unitOfMeasure': 'hours', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Rescue Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04531083 1000 mg', 'description': 'Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG001', 'title': 'PF-04531083 2000 mg', 'description': 'Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG002', 'title': 'Ibuprofen 400 mg', 'description': 'Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0 to 24 hours', 'description': 'Participants who did not experience adequate pain relief after 90 minutes post-dose of study medication had received 2 tablets of acetaminophen 500 mg as rescue medication.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration.'}, {'type': 'SECONDARY', 'title': 'Participant Global Evaluation of Study Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04531083 1000 mg', 'description': 'Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG001', 'title': 'PF-04531083 2000 mg', 'description': 'Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG002', 'title': 'Ibuprofen 400 mg', 'description': 'Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}], 'classes': [{'title': '6 hours: Excellent', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': '6 hours: Very Good', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': '6 hours: Good', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': '6 hours: Fair', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '6 hours: Poor', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '6 hours: Not Done', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}, {'title': '24 hours: Excellent', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': '24 hours: Very Good', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '24 hours: Good', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': '24 hours: Fair', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '24 hours: Poor', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '24 hours: Not Done', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}, {'title': 'Prior to RM: Excellent', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Prior to RM: Very Good', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Prior to RM: Good', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Prior to RM: Fair', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Prior to RM: Poor', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6, 24 hours, prior to RM', 'description': 'Participant rated the study medication that they received during the study, at both the 6 hour and 24 hour observations or at time of rescue medication, whichever occurs first, by answering the following question on 6-point categorical scale: how would you rate the study medication you received for pain? 5=excellent, 4=very good, 3=good, 2=fair and 1=poor.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. Participants analyzed in this outcome for prior to rescue medication included only those participants who took rescue medication.'}, {'type': 'SECONDARY', 'title': 'Participant Satisfaction Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04531083 1000 mg', 'description': 'Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG001', 'title': 'PF-04531083 2000 mg', 'description': 'Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG002', 'title': 'Ibuprofen 400 mg', 'description': 'Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}], 'classes': [{'title': '6 hours PR: Very Satisfied', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': '6 hours PR: Somewhat Satisfied', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': '6 hours PR: Neither Satisfied nor Dissatisfied', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': '6 hours PR: Somewhat Dissatisfied', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '6 hours PR: Very Dissatisfied', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '6 hours PR: Not Done', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}, {'title': '6 hours OP: Very Satisfied', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': '6 hours OP: Somewhat Satisfied', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': '6 hours OP: Neither Satisfied nor Dissatisfied', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': '6 hours OP: Somewhat Dissatisfied', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '6 hours OP: Very Dissatisfied', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '6 hours OP: Not Done', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}, {'title': '24 hours PR: Very Satisfied', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': '24 hours PR: Somewhat Satisfied', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': '24 hours PR: Neither Satisfied nor Dissatisfied', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '24 hours PR: Somewhat Dissatisfied', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '24 hours PR: Very Dissatisfied', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '24 hours PR: Not Done', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}, {'title': '24 hours OP: Very Satisfied', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': '24 hours OP: Somewhat Satisfied', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': '24 hours OP: Neither Satisfied nor Dissatisfied', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '24 hours OP: Somewhat Dissatisfied', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '24 hours OP: Very Dissatisfied', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '24 hours OP: Not Done', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}, {'title': 'Prior to RM, PR: Very Satisfied', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Prior to RM, PR: Somewhat Satisfied', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Prior to RM, PR:Neither Satisfied nor Dissatisfied', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Prior to RM, PR: Somewhat Dissatisfied', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Prior to RM, PR: Very Dissatisfied', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Prior to RM, OP: Very Satisfied', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Prior to RM, OP: Somewhat Satisfied', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Prior to RM, OP:Neither Satisfied nor Dissatisfied', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Prior to RM, OP: Somewhat Dissatisfied', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Prior to RM, OP: Very Dissatisfied', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6, 24 hours, prior to RM', 'description': 'Participant\'s response to 2 questions about "how satisfied or dissatisfied they were with the study medication for PR and overall performance (OP)" was obtained on a 5 point categorical scale, 1=very dissatisfied, 2=somewhat dissatisfied, 3=neither satisfied nor dissatisfied, 4=somewhat satisfied and 5=very satisfied.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants who had received at least 1 dose of study treatment and not received rescue medication of any type in the first 90 minutes following treatment administration. Participants analyzed in this outcome for prior to rescue medication included only those participants who took rescue medication.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of PF-04531083', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04531083 1000 mg', 'description': 'Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG001', 'title': 'PF-04531083 2000 mg', 'description': 'Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}], 'classes': [{'categories': [{'measurements': [{'value': '5761', 'spread': '1905.0', 'groupId': 'OG000'}, {'value': '9433', 'spread': '3527.0', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04531083', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04531083 1000 mg', 'description': 'Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG001', 'title': 'PF-04531083 2000 mg', 'description': 'Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.02', 'groupId': 'OG000', 'lowerLimit': '1.02', 'upperLimit': '6.28'}, {'value': '6.00', 'groupId': 'OG001', 'lowerLimit': '2.02', 'upperLimit': '24.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to 6 Hour [AUC (0-6)] of PF-04531083', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04531083 1000 mg', 'description': 'Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG001', 'title': 'PF-04531083 2000 mg', 'description': 'Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}], 'classes': [{'categories': [{'measurements': [{'value': '21920', 'spread': '7707.8', 'groupId': 'OG000'}, {'value': '34640', 'spread': '16408.0', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 1, 2, 4, 6 hours post-dose', 'description': 'AUC (0-6)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 6 hours post-dose concentration.', 'unitOfMeasure': 'nanogram*hour per milliliter (ng*hr/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to 24 Hour [AUC (0-24)] of PF-04531083', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04531083 1000 mg', 'description': 'Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG001', 'title': 'PF-04531083 2000 mg', 'description': 'Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}], 'classes': [{'categories': [{'measurements': [{'value': '80140', 'spread': '23571', 'groupId': 'OG000'}, {'value': '147100', 'spread': '49215', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose', 'description': 'AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose concentration.', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of Ibuprofen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibuprofen 400 mg', 'description': 'Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}], 'classes': [{'title': '(R)-Ibuprofen', 'categories': [{'measurements': [{'value': '10.93', 'spread': '4.6191', 'groupId': 'OG000'}]}]}, {'title': '(S)-Ibuprofen', 'categories': [{'measurements': [{'value': '12.10', 'spread': '3.7848', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose', 'unitOfMeasure': 'microgram per milliliter (mcg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ibuprofen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibuprofen 400 mg', 'description': 'Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}], 'classes': [{'title': '(R)-Ibuprofen', 'categories': [{'measurements': [{'value': '4.02', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '24.1'}]}]}, {'title': '(S)-Ibuprofen', 'categories': [{'measurements': [{'value': '4.02', 'groupId': 'OG000', 'lowerLimit': '1.02', 'upperLimit': '6.23'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to 6 Hour [AUC (0-6)] of Ibuprofen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibuprofen 400 mg', 'description': 'Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}], 'classes': [{'title': '(R)-Ibuprofen', 'categories': [{'measurements': [{'value': '31.39', 'spread': '12.847', 'groupId': 'OG000'}]}]}, {'title': '(S)-Ibuprofen', 'categories': [{'measurements': [{'value': '38.72', 'spread': '13.070', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 1, 2, 4, 6 hours post-dose', 'description': 'AUC (0-6)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 6 hours post-dose concentration.', 'unitOfMeasure': 'microgram*hour per milliliter (mcg*h/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to 24 Hour [AUC (0-24)] of Ibuprofen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibuprofen 400 mg', 'description': 'Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}], 'classes': [{'title': '(R)-Ibuprofen', 'categories': [{'measurements': [{'value': '56.82', 'spread': '49.272', 'groupId': 'OG000'}]}]}, {'title': '(S)-Ibuprofen', 'categories': [{'measurements': [{'value': '82.58', 'spread': '47.992', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose', 'description': 'AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose concentration.', 'unitOfMeasure': 'mcg*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included all randomized and treated participants for whom a PK sample was obtained and analyzed within the treatment period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04531083 1000 mg', 'description': 'Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG001', 'title': 'PF-04531083 2000 mg', 'description': 'Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG002', 'title': 'Ibuprofen 400 mg', 'description': 'Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Day 10-14 (Follow-up)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 10 to 14.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all randomized participants who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Laboratory Test Abnormality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04531083 1000 mg', 'description': 'Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG001', 'title': 'PF-04531083 2000 mg', 'description': 'Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG002', 'title': 'Ibuprofen 400 mg', 'description': 'Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Day 10-14 (Follow-up)', 'description': 'Hematology (hemoglobin, hematocrit, red blood cell count, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes); liver function (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, albumin, total protein); renal function (creatinine, blood urea nitrogen, uric acid, sodium, potassium, chloride, bicarbonate, calcium); urinalysis (urine pH, glucose, ketones, protein, blood, nitrite, leukocyte esterase), and clinical chemistry (glucose) were performed.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all randomized participants who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Supine Systolic and Diastolic Blood Pressure (BP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04531083 1000 mg', 'description': 'Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG001', 'title': 'PF-04531083 2000 mg', 'description': 'Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG002', 'title': 'Ibuprofen 400 mg', 'description': 'Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}], 'classes': [{'title': 'Screening: Systolic BP (n=22, 23, 22, 23)', 'categories': [{'measurements': [{'value': '124.3', 'spread': '9.70', 'groupId': 'OG000'}, {'value': '123.2', 'spread': '9.62', 'groupId': 'OG001'}, {'value': '122.4', 'spread': '10.05', 'groupId': 'OG002'}, {'value': '126.5', 'spread': '10.22', 'groupId': 'OG003'}]}]}, {'title': 'Screening: Diastolic BP (n=22, 23, 22, 23)', 'categories': [{'measurements': [{'value': '71.4', 'spread': '8.75', 'groupId': 'OG000'}, {'value': '69.7', 'spread': '6.33', 'groupId': 'OG001'}, {'value': '71.4', 'spread': '6.99', 'groupId': 'OG002'}, {'value': '72.8', 'spread': '8.31', 'groupId': 'OG003'}]}]}, {'title': 'Day 0: Systolic BP (n=22, 23, 22, 23)', 'categories': [{'measurements': [{'value': '128.2', 'spread': '14.41', 'groupId': 'OG000'}, {'value': '122.4', 'spread': '10.14', 'groupId': 'OG001'}, {'value': '126.7', 'spread': '11.15', 'groupId': 'OG002'}, {'value': '128.0', 'spread': '10.80', 'groupId': 'OG003'}]}]}, {'title': 'Day 0: Diastolic BP (n=22, 23, 22, 23)', 'categories': [{'measurements': [{'value': '71.8', 'spread': '10.52', 'groupId': 'OG000'}, {'value': '71.1', 'spread': '6.68', 'groupId': 'OG001'}, {'value': '71.6', 'spread': '6.75', 'groupId': 'OG002'}, {'value': '71.3', 'spread': '9.10', 'groupId': 'OG003'}]}]}, {'title': 'Day 1: Systolic BP (n=22, 23, 22, 23)', 'categories': [{'measurements': [{'value': '122.8', 'spread': '12.69', 'groupId': 'OG000'}, {'value': '126.8', 'spread': '13.17', 'groupId': 'OG001'}, {'value': '126.6', 'spread': '14.40', 'groupId': 'OG002'}, {'value': '124.1', 'spread': '14.39', 'groupId': 'OG003'}]}]}, {'title': 'Day 1: Diastolic BP (n=22, 23, 22, 23)', 'categories': [{'measurements': [{'value': '67.2', 'spread': '8.89', 'groupId': 'OG000'}, {'value': '71.1', 'spread': '9.59', 'groupId': 'OG001'}, {'value': '72.5', 'spread': '9.61', 'groupId': 'OG002'}, {'value': '70.7', 'spread': '11.51', 'groupId': 'OG003'}]}]}, {'title': 'Day 2: Systolic BP (n=22, 23, 22, 23)', 'categories': [{'measurements': [{'value': '121.2', 'spread': '10.51', 'groupId': 'OG000'}, {'value': '119.3', 'spread': '10.52', 'groupId': 'OG001'}, {'value': '124.0', 'spread': '11.39', 'groupId': 'OG002'}, {'value': '122.2', 'spread': '12.31', 'groupId': 'OG003'}]}]}, {'title': 'Day 2: Diastolic BP (n=22, 23, 22, 23)', 'categories': [{'measurements': [{'value': '65.9', 'spread': '9.26', 'groupId': 'OG000'}, {'value': '66.3', 'spread': '7.07', 'groupId': 'OG001'}, {'value': '67.7', 'spread': '8.90', 'groupId': 'OG002'}, {'value': '69.6', 'spread': '8.48', 'groupId': 'OG003'}]}]}, {'title': 'Day 10-14 (Follow-up): Systolic BP(n=21,23,22,22 )', 'categories': [{'measurements': [{'value': '122.8', 'spread': '11.05', 'groupId': 'OG000'}, {'value': '124.9', 'spread': '10.70', 'groupId': 'OG001'}, {'value': '125.4', 'spread': '11.14', 'groupId': 'OG002'}, {'value': '122.5', 'spread': '10.18', 'groupId': 'OG003'}]}]}, {'title': 'Day 10-14 (Follow-up): Diastolic BP(n=21,23,22,22)', 'categories': [{'measurements': [{'value': '69.7', 'spread': '11.32', 'groupId': 'OG000'}, {'value': '70.6', 'spread': '9.66', 'groupId': 'OG001'}, {'value': '72.1', 'spread': '5.56', 'groupId': 'OG002'}, {'value': '72.3', 'spread': '9.83', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening, Day 0, 1 (pre-dose), 2, 10-14 (Follow-up)', 'description': "Supine systolic and diastolic BP was measured after the participant has been rested in the supine position for at least 5 minutes with the participant's arm supported at the level of the heart, and recorded to the nearest millimeters of mercury (mmHg). The same arm and position and same size BP cuff was used throughout the study.", 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all randomized participants who received at least 1 dose of study treatment. n=number of participants evaluable for this measure at specified time point.'}, {'type': 'SECONDARY', 'title': '12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04531083 1000 mg', 'description': 'Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG001', 'title': 'PF-04531083 2000 mg', 'description': 'Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG002', 'title': 'Ibuprofen 400 mg', 'description': 'Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}], 'classes': [{'title': 'Screening: PR Interval (n=22, 23, 22, 23)', 'categories': [{'measurements': [{'value': '157.1', 'spread': '27.69', 'groupId': 'OG000'}, {'value': '156.0', 'spread': '20.64', 'groupId': 'OG001'}, {'value': '150.7', 'spread': '23.17', 'groupId': 'OG002'}, {'value': '156.4', 'spread': '22.12', 'groupId': 'OG003'}]}]}, {'title': 'Screening: QRS Interval (n=22, 23, 22, 23)', 'categories': [{'measurements': [{'value': '90.3', 'spread': '8.33', 'groupId': 'OG000'}, {'value': '95.8', 'spread': '9.96', 'groupId': 'OG001'}, {'value': '93.2', 'spread': '8.74', 'groupId': 'OG002'}, {'value': '93.7', 'spread': '8.68', 'groupId': 'OG003'}]}]}, {'title': 'Screening: QT Interval (n=22, 23, 22, 23)', 'categories': [{'measurements': [{'value': '398.4', 'spread': '34.27', 'groupId': 'OG000'}, {'value': '413.2', 'spread': '34.29', 'groupId': 'OG001'}, {'value': '410.7', 'spread': '25.43', 'groupId': 'OG002'}, {'value': '410.3', 'spread': '26.56', 'groupId': 'OG003'}]}]}, {'title': 'Screening: QTcF Interval (n=22, 23, 22, 23)', 'categories': [{'measurements': [{'value': '399.8', 'spread': '16.34', 'groupId': 'OG000'}, {'value': '403.6', 'spread': '18.33', 'groupId': 'OG001'}, {'value': '400.9', 'spread': '16.33', 'groupId': 'OG002'}, {'value': '404.0', 'spread': '17.03', 'groupId': 'OG003'}]}]}, {'title': 'Day 1: PR Interval (n=22, 23, 22, 23)', 'categories': [{'measurements': [{'value': '154.2', 'spread': '21.51', 'groupId': 'OG000'}, {'value': '148.7', 'spread': '18.71', 'groupId': 'OG001'}, {'value': '148.4', 'spread': '23.81', 'groupId': 'OG002'}, {'value': '152.5', 'spread': '14.93', 'groupId': 'OG003'}]}]}, {'title': 'Day 1: QRS Interval (n=22, 23, 22, 23)', 'categories': [{'measurements': [{'value': '89.7', 'spread': '7.15', 'groupId': 'OG000'}, {'value': '95.0', 'spread': '9.96', 'groupId': 'OG001'}, {'value': '91.5', 'spread': '7.90', 'groupId': 'OG002'}, {'value': '90.8', 'spread': '8.96', 'groupId': 'OG003'}]}]}, {'title': 'Day 1: QT Interval (n=22, 23, 22, 23)', 'categories': [{'measurements': [{'value': '372.0', 'spread': '18.27', 'groupId': 'OG000'}, {'value': '391.1', 'spread': '27.39', 'groupId': 'OG001'}, {'value': '388.7', 'spread': '28.41', 'groupId': 'OG002'}, {'value': '388.9', 'spread': '28.00', 'groupId': 'OG003'}]}]}, {'title': 'Day 1: QTcF Interval (n=22, 23, 22, 23)', 'categories': [{'measurements': [{'value': '388.5', 'spread': '15.48', 'groupId': 'OG000'}, {'value': '393.4', 'spread': '18.82', 'groupId': 'OG001'}, {'value': '395.3', 'spread': '17.66', 'groupId': 'OG002'}, {'value': '398.7', 'spread': '15.14', 'groupId': 'OG003'}]}]}, {'title': 'Day 2: PR Interval (n=22, 23, 22, 23)', 'categories': [{'measurements': [{'value': '156.9', 'spread': '22.83', 'groupId': 'OG000'}, {'value': '149.1', 'spread': '17.79', 'groupId': 'OG001'}, {'value': '150.8', 'spread': '22.86', 'groupId': 'OG002'}, {'value': '153.9', 'spread': '18.33', 'groupId': 'OG003'}]}]}, {'title': 'Day 2: QRS Interval (n=22, 23, 22, 23)', 'categories': [{'measurements': [{'value': '87.6', 'spread': '7.63', 'groupId': 'OG000'}, {'value': '93.7', 'spread': '8.10', 'groupId': 'OG001'}, {'value': '88.5', 'spread': '11.73', 'groupId': 'OG002'}, {'value': '90.4', 'spread': '8.38', 'groupId': 'OG003'}]}]}, {'title': 'Day 2: QT Interval (n=22, 23, 22, 23)', 'categories': [{'measurements': [{'value': '381.1', 'spread': '24.91', 'groupId': 'OG000'}, {'value': '395.5', 'spread': '32.99', 'groupId': 'OG001'}, {'value': '385.8', 'spread': '32.91', 'groupId': 'OG002'}, {'value': '396.7', 'spread': '26.22', 'groupId': 'OG003'}]}]}, {'title': 'Day 2: QTcF Interval (n=22, 23, 22, 23)', 'categories': [{'measurements': [{'value': '394.0', 'spread': '14.76', 'groupId': 'OG000'}, {'value': '397.9', 'spread': '18.87', 'groupId': 'OG001'}, {'value': '396.6', 'spread': '19.03', 'groupId': 'OG002'}, {'value': '404.2', 'spread': '16.82', 'groupId': 'OG003'}]}]}, {'title': 'Day 10-14 (Follow-up): PR Interval (n=0, 0, 0, 1)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.', 'groupId': 'OG002'}, {'value': '148.0', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only 1 participant was evaluable.', 'groupId': 'OG003'}]}]}, {'title': 'Day 10-14 (Follow-up): QRS Interval (n=0, 0, 0, 1)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.', 'groupId': 'OG002'}, {'value': '102.0', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only 1 participant was evaluable.', 'groupId': 'OG003'}]}]}, {'title': 'Day 10-14 (Follow-up): QT Interval (n=0, 0, 0, 1)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.', 'groupId': 'OG002'}, {'value': '360.0', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only 1 participant was evaluable.', 'groupId': 'OG003'}]}]}, {'title': 'Day 10-14 (Follow-up): QTcF Interval(n=0, 0, 0, 1)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.', 'groupId': 'OG002'}, {'value': '401.0', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only 1 participant was evaluable.', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening, Day 1, 2, 10-14 (Follow-up)', 'description': "Standard 12-lead ECG was performed after the participant has rested quietly for at least 10 minutes in a supine position. ECG intervals included PR interval (time between the onset of atrial depolarization and the onset of ventricular depolarization), QRS interval (represented ventricular depolarization) and QT interval (time corresponding to the beginning of depolarization to repolarization of the ventricles) corrected using Fridericia's formula (QTcF = QT divided by cube root of RR interval).", 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all randomized participants who received at least 1 dose of study treatment. n=number of participants evaluable for this measure at specified time points for each arm group respectively.'}, {'type': 'SECONDARY', 'title': '12-Lead Electrocardiogram (ECG) Parameter (Heart Rate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04531083 1000 mg', 'description': 'Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG001', 'title': 'PF-04531083 2000 mg', 'description': 'Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG002', 'title': 'Ibuprofen 400 mg', 'description': 'Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}], 'classes': [{'title': 'Screening (n=22, 23, 22, 23)', 'categories': [{'measurements': [{'value': '62.2', 'spread': '11.99', 'groupId': 'OG000'}, {'value': '57.1', 'spread': '10.02', 'groupId': 'OG001'}, {'value': '56.5', 'spread': '8.05', 'groupId': 'OG002'}, {'value': '58.0', 'spread': '8.54', 'groupId': 'OG003'}]}]}, {'title': 'Day 1 (n=22, 23, 22, 23)', 'categories': [{'measurements': [{'value': '69.1', 'spread': '10.30', 'groupId': 'OG000'}, {'value': '61.7', 'spread': '7.08', 'groupId': 'OG001'}, {'value': '64.0', 'spread': '9.51', 'groupId': 'OG002'}, {'value': '65.8', 'spread': '10.89', 'groupId': 'OG003'}]}]}, {'title': 'Day 2 (n=22, 23, 22, 23)', 'categories': [{'measurements': [{'value': '67.2', 'spread': '9.83', 'groupId': 'OG000'}, {'value': '62.5', 'spread': '11.60', 'groupId': 'OG001'}, {'value': '66.3', 'spread': '10.09', 'groupId': 'OG002'}, {'value': '64.3', 'spread': '8.26', 'groupId': 'OG003'}]}]}, {'title': 'Day 10-14 (Follow-up) (n=0, 0, 0, 1)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As planned follow-up visit ECG was not done since no significant change was observed during the 6 and 24 hours post-dose ECGs.', 'groupId': 'OG002'}, {'value': '83.0', 'spread': 'NA', 'comment': 'Standard deviation was not estimable since only 1 participant was evaluable.', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening, Day 1, 2, 10-14 (Follow-up)', 'description': 'Standard 12-lead ECG was performed after the participant has rested quietly for at least 10 minutes in a supine position. The time interval between consecutive heart beats (RR interval) was used to calculate heart rate.', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all randomized participants who received at least 1 dose of study treatment. n=number of participants evaluable for this measure at specified time points for each arm group respectively.'}, {'type': 'SECONDARY', 'title': 'Supine Pulse Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04531083 1000 mg', 'description': 'Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG001', 'title': 'PF-04531083 2000 mg', 'description': 'Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG002', 'title': 'Ibuprofen 400 mg', 'description': 'Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}], 'classes': [{'title': 'Screening (n=22, 23, 22, 23)', 'categories': [{'measurements': [{'value': '60.1', 'spread': '13.08', 'groupId': 'OG000'}, {'value': '56.2', 'spread': '10.48', 'groupId': 'OG001'}, {'value': '55.1', 'spread': '7.97', 'groupId': 'OG002'}, {'value': '57.0', 'spread': '10.45', 'groupId': 'OG003'}]}]}, {'title': 'Day 0 (n=22,23,22,23)', 'categories': [{'measurements': [{'value': '61.6', 'spread': '8.56', 'groupId': 'OG000'}, {'value': '61.3', 'spread': '9.89', 'groupId': 'OG001'}, {'value': '62.1', 'spread': '10.23', 'groupId': 'OG002'}, {'value': '63.1', 'spread': '12.40', 'groupId': 'OG003'}]}]}, {'title': 'Day 1 (n=22,23,22,23)', 'categories': [{'measurements': [{'value': '66.4', 'spread': '10.06', 'groupId': 'OG000'}, {'value': '59.5', 'spread': '8.81', 'groupId': 'OG001'}, {'value': '61.2', 'spread': '7.32', 'groupId': 'OG002'}, {'value': '59.4', 'spread': '9.48', 'groupId': 'OG003'}]}]}, {'title': 'Day 2 (n=22,23,22,23)', 'categories': [{'measurements': [{'value': '64.1', 'spread': '9.59', 'groupId': 'OG000'}, {'value': '60.6', 'spread': '12.03', 'groupId': 'OG001'}, {'value': '65.9', 'spread': '8.71', 'groupId': 'OG002'}, {'value': '62.7', 'spread': '8.55', 'groupId': 'OG003'}]}]}, {'title': 'Day 10-14 (Follow-up) (n=21, 23, 22, 22)', 'categories': [{'measurements': [{'value': '61.3', 'spread': '9.91', 'groupId': 'OG000'}, {'value': '60.4', 'spread': '10.60', 'groupId': 'OG001'}, {'value': '59.6', 'spread': '11.81', 'groupId': 'OG002'}, {'value': '62.0', 'spread': '8.91', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Screening, Day 0, 1 (pre-dose), 2, 10-14 (Follow-up)', 'description': 'Supine pulse rate was measured in the brachial/radial artery for at least 30 seconds.', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all randomized participants who received at least 1 dose of study treatment. n=number of participants evaluable for this measure at specified time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PF-04531083 1000 mg', 'description': 'Single oral dose of PF-04531083 1000 milligram (mg) spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 millimeter (mm) on a 100 mm Visual Analogue Scale (VAS).'}, {'id': 'FG001', 'title': 'PF-04531083 2000 mg', 'description': 'Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'FG002', 'title': 'Ibuprofen 400 mg', 'description': 'Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '90', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'PF-04531083 1000 mg', 'description': 'Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'BG001', 'title': 'PF-04531083 2000 mg', 'description': 'Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'BG002', 'title': 'Ibuprofen 400 mg', 'description': 'Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '22.9', 'spread': '3.7', 'groupId': 'BG000'}, {'value': '23.4', 'spread': '5.7', 'groupId': 'BG001'}, {'value': '25.3', 'spread': '4.5', 'groupId': 'BG002'}, {'value': '25.3', 'spread': '5.4', 'groupId': 'BG003'}, {'value': '24.2', 'spread': '4.9', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '90', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'whyStopped': 'See termination reason in detailed description.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-23', 'studyFirstSubmitDate': '2011-08-30', 'resultsFirstSubmitDate': '2013-03-14', 'studyFirstSubmitQcDate': '2012-01-13', 'lastUpdatePostDateStruct': {'date': '2013-06-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-05-23', 'studyFirstPostDateStruct': {'date': '2012-01-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Pain Relief (TOTPAR) Score From 0 to 6 Hours', 'timeFrame': '0 to 6 hours', 'description': 'TOTPAR \\[6\\] was defined as the area under the pain relief (PR) curve through the first 6 hours after dosing. Area under the curve (AUC) was calculated using the trapezoid rule with PR was assumed to be 0 at time=0. PR assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at 15, 30, 45, minutes and at different time points during the study up to 6 hours post-dose. Total score range for TOTPAR \\[6\\]: 0 (worst) - 24 (best), higher value of TOTPAR indicated greater degree of PR.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Peak Pain Relief (PPR)', 'timeFrame': '0 to 24 hours', 'description': 'PPR was defined as the highest PR score achieved at any time point during the evaluation period, prior to rescue medication. PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete).'}, {'measure': 'Time-specific Pain Relief (PR) Score', 'timeFrame': '0, 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 24 hours, prior to rescue medication (RM)', 'description': 'PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete) at each relevant time points.'}, {'measure': 'Time-specific Pain Intensity Difference (PID) Score', 'timeFrame': '15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8, 24 hours, prior to RM', 'description': 'Pain intensity was assessed on a categorical scale ranging from 0 (none), 1 (mild), 2 (moderate) and 3 (severe). PID was calculated as pain intensity at baseline minus pain intensity at the respective post-baseline visit.'}, {'measure': 'Summed Pain Intensity Difference (SPID) Score at 6 Hours and 24 Hours', 'timeFrame': '0 to 6, 0 to 24 hours', 'description': 'Pain intensity was assessed on a categorical scale ranging from 0 (none), 1 (mild), 2 (moderate) and 3 (severe). PID was calculated as pain intensity at baseline minus pain intensity at the respective post-baseline visit. The SPID at 6 and 24 hours was derived by calculating the area under the PID effect curve through the first 6 or 24 hours post-dose respectively. The AUC was calculated using the trapezoid rule. Total score range: -6 (worst) to 18 (best) for SPID 0-6, and -24 (worst) to 72 (best) for SPID 0-24. Higher value of SPID indicated greater degree of pain relief.'}, {'measure': 'Total Pain Relief (TOTPAR) Score From 0 to 24 Hours', 'timeFrame': '0 to 24 hours', 'description': 'TOTPAR \\[24\\] was defined as the area under the pain relief (PR) curve through the 24 hours after dosing. Area under the curve (AUC) was calculated using the trapezoid rule with PR assumed to be 0 at time=0. PR was assessed on a 5-point categorical scale; 0 (none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at 15, 30, 45, minutes and at different time points during the study up to 24 hours post-dose. Total score range for TOTPAR \\[24\\]: 0 (worst) - 96 (best), higher value of TOTPAR indicated greater degree of PR.'}, {'measure': 'Time to Onset of First Perceptible Pain Relief (PR)', 'timeFrame': '0 to 24 hours', 'description': "Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment they first began to experience any relief."}, {'measure': 'Time to Onset of First Meaningful Pain Relief (PR)', 'timeFrame': '0 to 24 hours', 'description': "Participants evaluated the time to first meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment they first began to experience meaningful relief."}, {'measure': 'Time to First Use of Rescue Medication', 'timeFrame': '1.5 to 24 hours', 'description': 'Time to first use of rescue medication (2 tablets of acetaminophen 500 mg as starting dose) was calculated by subtracting time of first administration of study medication from the rescue medication administration time.'}, {'measure': 'Number of Participants With Rescue Medication', 'timeFrame': '0 to 24 hours', 'description': 'Participants who did not experience adequate pain relief after 90 minutes post-dose of study medication had received 2 tablets of acetaminophen 500 mg as rescue medication.'}, {'measure': 'Participant Global Evaluation of Study Medication', 'timeFrame': '6, 24 hours, prior to RM', 'description': 'Participant rated the study medication that they received during the study, at both the 6 hour and 24 hour observations or at time of rescue medication, whichever occurs first, by answering the following question on 6-point categorical scale: how would you rate the study medication you received for pain? 5=excellent, 4=very good, 3=good, 2=fair and 1=poor.'}, {'measure': 'Participant Satisfaction Questionnaire', 'timeFrame': '6, 24 hours, prior to RM', 'description': 'Participant\'s response to 2 questions about "how satisfied or dissatisfied they were with the study medication for PR and overall performance (OP)" was obtained on a 5 point categorical scale, 1=very dissatisfied, 2=somewhat dissatisfied, 3=neither satisfied nor dissatisfied, 4=somewhat satisfied and 5=very satisfied.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of PF-04531083', 'timeFrame': '0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04531083', 'timeFrame': '0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose'}, {'measure': 'Area Under the Curve From Time Zero to 6 Hour [AUC (0-6)] of PF-04531083', 'timeFrame': '0 (pre-dose), 1, 2, 4, 6 hours post-dose', 'description': 'AUC (0-6)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 6 hours post-dose concentration.'}, {'measure': 'Area Under the Curve From Time Zero to 24 Hour [AUC (0-24)] of PF-04531083', 'timeFrame': '0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose', 'description': 'AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose concentration.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of Ibuprofen', 'timeFrame': '0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of Ibuprofen', 'timeFrame': '0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose'}, {'measure': 'Area Under the Curve From Time Zero to 6 Hour [AUC (0-6)] of Ibuprofen', 'timeFrame': '0 (pre-dose), 1, 2, 4, 6 hours post-dose', 'description': 'AUC (0-6)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 6 hours post-dose concentration.'}, {'measure': 'Area Under the Curve From Time Zero to 24 Hour [AUC (0-24)] of Ibuprofen', 'timeFrame': '0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose', 'description': 'AUC (0-24)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours post-dose concentration.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)', 'timeFrame': 'Baseline up to Day 10-14 (Follow-up)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Day 10 to 14.'}, {'measure': 'Number of Participants With Clinically Significant Laboratory Test Abnormality', 'timeFrame': 'Baseline up to Day 10-14 (Follow-up)', 'description': 'Hematology (hemoglobin, hematocrit, red blood cell count, platelets, leukocytes, total neutrophils, eosinophils, basophils, lymphocytes, monocytes); liver function (total bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, albumin, total protein); renal function (creatinine, blood urea nitrogen, uric acid, sodium, potassium, chloride, bicarbonate, calcium); urinalysis (urine pH, glucose, ketones, protein, blood, nitrite, leukocyte esterase), and clinical chemistry (glucose) were performed.'}, {'measure': 'Supine Systolic and Diastolic Blood Pressure (BP)', 'timeFrame': 'Screening, Day 0, 1 (pre-dose), 2, 10-14 (Follow-up)', 'description': "Supine systolic and diastolic BP was measured after the participant has been rested in the supine position for at least 5 minutes with the participant's arm supported at the level of the heart, and recorded to the nearest millimeters of mercury (mmHg). The same arm and position and same size BP cuff was used throughout the study."}, {'measure': '12-Lead Electrocardiogram (ECG) Parameters (PR, QRS, QT, QTcF Intervals)', 'timeFrame': 'Screening, Day 1, 2, 10-14 (Follow-up)', 'description': "Standard 12-lead ECG was performed after the participant has rested quietly for at least 10 minutes in a supine position. ECG intervals included PR interval (time between the onset of atrial depolarization and the onset of ventricular depolarization), QRS interval (represented ventricular depolarization) and QT interval (time corresponding to the beginning of depolarization to repolarization of the ventricles) corrected using Fridericia's formula (QTcF = QT divided by cube root of RR interval)."}, {'measure': '12-Lead Electrocardiogram (ECG) Parameter (Heart Rate)', 'timeFrame': 'Screening, Day 1, 2, 10-14 (Follow-up)', 'description': 'Standard 12-lead ECG was performed after the participant has rested quietly for at least 10 minutes in a supine position. The time interval between consecutive heart beats (RR interval) was used to calculate heart rate.'}, {'measure': 'Supine Pulse Rate', 'timeFrame': 'Screening, Day 0, 1 (pre-dose), 2, 10-14 (Follow-up)', 'description': 'Supine pulse rate was measured in the brachial/radial artery for at least 30 seconds.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Post-surgical dental pain'], 'conditions': ['Post-surgical Dental Pain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1351010&StudyName=Efficacy%20Of%20Pf-04531083%20In%20Treating%20Post-Surgical%20Dental%20Pain', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the overall pain relief of a single dose of PF-04531083 against placebo following third molar extraction.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Oral surgical procedure having removed 2 third molars (unilateral).\n* Pre-dose pain intensity score (100 mm Visual Analog Scale \\[VAS\\]) \\>50 mm within 5 hours of oral surgery.\n* Pre-dose pain intensity score of moderate or within 5 hours of oral surgery.\n\nExclusion Criteria:\n\n* Presence or history of any significant hepatic, renal, endocrine, cardiovascular, neurological (including subjects with a history of frequent moderate to severe headaches or subjects with episodic migraines more than twice per month), psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorder.\n* Prior use of any type of analgesic or NSAID within five half-lives of that drug or less before taking the first dose of study medication, except for anesthesia for the procedure.\n* Recent history of chronic analgesic or tranquilizer dependency.\n* Active dental infection at the time of surgery.\n* Any significant oral surgery complication at the time of surgery or in the immediate postoperative period or dental surgery lasting \\> 30 minutes.\n* Subjects who are smokers.'}, 'identificationModule': {'nctId': 'NCT01512160', 'briefTitle': 'Efficacy Of Pf-04531083 In Treating Post-Surgical Dental Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Randomized, Double-Blind Third Party Open, Double-Dummy, Parallel Group, Placebo Controlled Study Assessing The Efficacy Of Single Doses Of Pf-04531083 For The Treatment Of Post-Surgical Dental Pain Using Ibuprofen 400 Mg As A Positive Control', 'orgStudyIdInfo': {'id': 'B1351010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PF-04531083 2000 mg', 'interventionNames': ['Drug: PF-04531083', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'PF-04531083 1000 mg', 'interventionNames': ['Drug: PF-04531083', 'Other: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ibuprofen 400 mg', 'interventionNames': ['Drug: Ibuprofen', 'Other: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'PF-04531083', 'type': 'DRUG', 'description': '2000 mg oral solution', 'armGroupLabels': ['PF-04531083 2000 mg']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo tablets for Ibuprofen', 'armGroupLabels': ['PF-04531083 2000 mg']}, {'name': 'PF-04531083', 'type': 'DRUG', 'description': '1000 mg oral solution', 'armGroupLabels': ['PF-04531083 1000 mg']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo tablets for Ibuprofen', 'armGroupLabels': ['PF-04531083 1000 mg']}, {'name': 'Ibuprofen', 'type': 'DRUG', 'description': '2 x 200 mg tablets', 'armGroupLabels': ['Ibuprofen 400 mg']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo solution for PF-04531083', 'armGroupLabels': ['Ibuprofen 400 mg']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo solution for PF-04531083', 'armGroupLabels': ['Placebo']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo tablets for Ibuprofen', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78744', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}